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- PMLiVE

FDA rejects ViiV’s long-acting monthly HIV injection

Blow to company as it hopes to capture market share from Gilead

- PMLiVE

Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

- PMLiVE

Trump administration advances drug importation plan

Proposal would allow states to import drugs from Canada

- PMLiVE

GSK files anti-BCMA drug for myeloma after second trial win

Important drug for GSK as it rebuilds R&D pipeline

- PMLiVE

UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner

Final Senate vote was 72 to 18 in favour of the radiation oncology expert

- PMLiVE

Horizon looks bright as FDA panel backs eye drug teprotumumab

First alternative to surgery for proptosis

- PMLiVE

FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

Initially had concerns about infection risks and kidney toxicity

- PMLiVE

Biogen defends aducanumab filing plan amid scepticism

A new look at pivotal trial data described as hard-to-interpret

- PMLiVE

J&J to FDA: there really is no asbestos in Baby Powder

Rejects findings that product contained 'sub-trace' levels of asbestos

- PMLiVE

Biogen scores mid-stage trial win for lupus drug BIIB059

Last approved treatment for Lupus was GSK's Benlysta in 2011

- PMLiVE

Amarin files fish oil-based heart drug Vascepa in Europe

FDA verdict is also due for expanded use of the drug

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